CurrentCentenePolicy CP PHAR.195

Riociguat (Adempas) Coverage Criteria

Defines medical necessity, initial and continued therapy criteria, dosing limits, contraindications, and approval durations for riociguat (Adempas) for members in Centene lines of business.

Policy Summary

PayerCentene

PolicyRiociguat (Adempas) Coverage Criteria

Policy CodePolicy CP PHAR.195

Change TypeNo material changes

Effective DateMar 16, 2024

Next Review Date

Key ActionProvider must submit clinical documentation (office notes, labs, etc.) demonstrating the member meets all approval criteria, including diagnosis of PAH or CTEPH and required dosing limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7.5 mg/daymaximum daily dose stated

3 tablets/daymaximum tablets per day

Medicaid/HIM: 6 moinitial approval duration

Commercial: 12 moapproval duration (initial/continued)

Commercial, HIM, Medicaidapplies to

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Initial Therapy

Covered when ALL of the following are met:

Initial Approval: 1. Member has a documented diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).

Prescriber: 2. Therapy is prescribed by or in consultation with a cardiologist or pulmonologist.

PAH-specific requirement: 3. For PAH: one of the following must be met: (a) failure of a calcium channel blocker (see Appendix B); OR (b) inadequate response to acute vasodilator testing; OR (c) contraindication or clinically significant adverse effects to calcium channel blockers.

CTEPH-specific requirement: 4. For CTEPH: disease is inoperable or persistent/recurrent with suboptimal surgical outcome.

Dose limits: 5. Requested dose does not exceed both of the following: a) 7.5 mg per day; AND b) 3 tablets per day (note: members who smoke may require higher doses).dose <= 7.5 mg/day AND tablets <= 3/day

Provider must submit supporting documentation.

Continuation Therapy

Continued therapy is covered when ALL of the following are met:

Current/previous approval: 1. Member is currently receiving the medication via the Centene benefit or has previously met the initial approval criteria.

Clinical response: 2. Member is demonstrating a positive clinical response to therapy.

Dose limits for continuation: 3. If a dose increase is requested, the new dose does not exceed both: a) 7.5 mg per day; AND b) 3 tablets per day (members who smoke may require higher doses).dose <= 7.5 mg/day AND tablets <= 3/day

Continuity of care may apply per state/product regulations.

Dosing and formulation details

Clinical dosing and formulation details referenced for use decisions

Dosing for PAH: Start riociguat 1 mg orally three times daily (TID) and increase by 0.5 mg every 2 weeks as tolerated.max 7.5 mg/day

Titration schedule and maximum dose per product dosing guidance.

Dosing for CTEPH: Titrate as tolerated to target dose of 2.5 mg three times daily (TID).target 2.5 mg TID

CTEPH-specific titration target stated in dosing guidance.

Formulations: Tablet strengths available: 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg.

Product availability of oral tablet formulations.

Requests for riociguat (Adempas) for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with Centene off‑label use requirements. Providers should follow the applicable off‑label use policy (e.g., CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid) or other evidence‑of‑coverage documentation when submitting such requests.

When coverage provisions in this clinical policy conflict with state Medicaid requirements, the state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules and any state‑level exceptions that override this policy.

Requests for riociguat for non‑FDA approved indications that lack adequate supporting evidence will be considered not medically necessary. Providers must submit clinical data and references that meet the standards in the relevant off‑label use policy to support coverage for such indications.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include a documented diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) and evidence that all initial or continued therapy criteria in this policy are met.

PAH or CTEPH diagnosis documented in chart notes or referral
Evidence that member meets initial or continuation criteria per policy

Denial Risk

Non‑Covered Indications / Off‑Label Requests

Requests for indications that are not FDA‑approved and not addressed in this policy may be denied unless sufficient supporting documentation is provided per the applicable off‑label use policy. For commercial members, refer to CP CPA.09; for Health Insurance Marketplace, refer to HIM.PA.154; for Medicaid, refer to CP PMN.53. Provide evidence of efficacy and safety when seeking coverage for off‑label use.

Non‑FDA approved indications require documentation per off‑label use policies (CP CPA.09, HIM.PA.154, CP PMN.53)
Include clinical evidence supporting efficacy and safety for the requested off‑label indication

Note

Approval Duration Changes

Commercial approval duration has been revised: approvals for the Commercial line of business are limited to 12 months or the duration of the request, whichever is less. Ensure requests specify the requested approval duration.

Commercial: Approval duration = 12 months or duration of request, whichever is less
Medicaid: follow Medicaid-specific duration criteria as indicated in policy

Step Therapy

Therapeutic Failure / Alternatives

Therapeutic failure or trial of alternatives is required for PAH: unless an exception applies, documentation of failure of a calcium channel blocker is required, or documentation of inadequate response/contraindication to acute vasodilator testing. See Appendix B for recommended therapeutic alternatives and dosing. If a calcium channel blocker is contraindicated or not tolerated, provide clinical rationale and supporting documentation.

PAH: Failure of a calcium channel blocker required unless inadequate response or contraindication to acute vasodilator testing is documented
Appendix B lists therapeutic alternatives (e.g., nifedipine, diltiazem, amlodipine) and dosing information
If exception to trial is claimed, include documentation of contraindication or clinically significant adverse effects

Documentation Required

Continuation / Template Note

For continuation of therapy, use the revised template language applied across diagnoses/indications. Requests for continued therapy must include documentation that the member previously met initial criteria or is currently responding positively to therapy. If requesting a dose increase, include rationale and ensure the new dose does not exceed policy limits.

Continuation requests must document prior approval or that initial criteria were previously met
Document positive clinical response to therapy for continuation
Dose increases require supporting clinical justification and must not exceed maximum dose limits specified in policy

Documentation Required

Clinical Documentation Required

Provider must submit clinical documentation (such as office chart notes, laboratory results, imaging, procedure reports, and consultation notes) supporting that the member meets all approval criteria. Lack of adequate documentation may result in denial.

Include office notes, labs, imaging, procedural documentation, and specialist consultation when applicable
Clearly document diagnosis (PAH or CTEPH), prior therapies/trials, contraindications, and response to treatment

Note

Supporting References

Prescribing information and Clinical Pharmacology references are cited as authoritative sources and should be provided or referenced to support requests when relevant.

Adempas prescribing information (Bayer)
Clinical Pharmacology database (Elsevier)
Relevant clinical guidelines and peer-reviewed literature cited in policy references

OpenPayer

Riociguat (Adempas) Coverage Criteria

Coverage Criteria for Riociguat (Adempas)

Coding and Dose Limits

Provider Actions, Prior Authorization, and Documentation

Background

Definitions